Medical DevicesMedical devices have
long been known to society. Everyone who has read Treasure Island realizes
that the peg-leg pirate was actually the recipient of an orthopaedic prosthesis.
Peg legs have been replaced by lifelike prosthesis and the ever-expanding
list of medical devices now includes orthopaedic bone screws, pedicle
screws, breast implants, contraceptive implants (including Norplant),
penile implants and heart valves. While many medical devices are safe
and effective for their intended uses, many others, including some of
the above listed, are not.

Medical devices are
produced by various manufacturers both large and small. Large corporations
include Bristol Meyers Squibb, Dow Corning and 3M. Smaller corporations
include Mentor, Acromed, and literally hundreds of others. This list is
by no means all-inclusive.

Medical devices for
use and sale in the United States are governed by the Food and Drug Administration
(FDA). The FDA was established in 1931 but it was not until the 1976 Medical
Device Amendments to the Food, Drug & Cosmetic act that the FDA was given
power over medical devices. This act sought to provide "reasonable assurance
of safety and effectiveness" for all devices.

Because of the complexity
and diversity of medical devices, two different methods were devised by
the FDA to group them. Devices are categorized into three classes ( I,
II, III) based upon the amount of risk involved in the use of that device.
In addition to "classes", devices are divided into seven different categories
which relate to the 1976 amendment: pre-market, post-market, substantially
equivalent, implant, custom, investigational, and transitional. The classes
and categories determine the level of scrutiny that a device must undergo
in order to reach the market.

The largest group
of medical devices which have become the subject of litigation involve
those devices which are class III, substantially equivalent. Class III
medical devices consist of those devices which present a potentially unreasonable
risk of injury. Devices are "substantially equivalent" if the FDA finds
that a device which was in existence and use prior to the 1976 amendment
is substantially equivalent to a device which is proposed to be marketed
today. The logic is that if a device has been in use since before 1976
then similar devices need not go through rigorous testing because the
device is tested by time. In theory this is true, but all to often companies
will propose a device for approval as "substantially equivalent" when
there truly are significant differences, simply in order to gain approval
without costly and time-consuming test trials. Litigation arises more
often than not in this fact pattern.

When using a medical
device, it is incumbent upon the doctor to disclose to the patient the
risks attached to the use of this device. Failure to give such informed
consent may, in some states, give rise to a claim for malpractice against
the doctor.

This informational piece was prepared by Monheit, Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" button on this web site.